The Stop the Importation and Manufacturing of Synthetic Analogues (SIMSA) Act of 2019 (HR 4963) seeks to establish a framework for regulating analogs of controlled substances that are imported, or offered for import, into the US.
Specifically, the bill would amend the Controlled Substances Act to create a sixth schedule of controlled substances, schedule A, which would encompass substances that are structurally and functionally similar (i.e., analogs) to drugs controlled under schedules I-V but not yet regulated in the US. The criteria for inclusion under schedule A would also include:
- Having a known or predicted depressant, hallucinogenic, stimulant, or other neurological effect that is comparable to substance controlled under schedules I-V, based on available scientific evidence on the substance’s chemical composition and mode of action;
- Carrying a high risk of abuse, dependence, diversion from legitimate sources, or clandestine import into the US that is comparable to that of substances controlled under schedules I-V; and
- Not being exempt from regulation under provisions of the Federal Food and Cosmetics Act, which authorizes the use of a substance in research or medicine
Following the establishment of schedule A, the US Department of Justice (DOJ) would be able to temporarily schedule a chemical analog for a period of five years, if it is concluded that doing so would help curb the risk of the substance’s abuse. If the substance is proven to satisfy the abovementioned criteria for inclusion under schedule A after 3 years of temporary regulation, the DOJ, in consultation with the US Department of Health and Human Services, would issue a permanent scheduling order for the substance in question.
In addition, the SIMSA Act would amend the Controlled Substances Import and Export Act to prohibit the import, export, distribution, or dispensing of a schedule A substance, unless that substance is registered with the DOJ for legitimate research, medical, or industrial use. In approving registration requests, the DOJ may consider a substance’s potential to advance such technical fields and the feasibility of establishing effective controls against its diversion or misuse, among other factors.
Individuals attempting to transact schedule A substances without registering with the DOJ would be subject to similar criminal sanctions as those imposed on the transaction of schedule I-V substances under the Controlled Substances Import and Export Act.